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Self-collected Swabs for HPV Testing in 18-24 Year Old Women (DRY)

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ClinicalTrials.gov Identifier: NCT01101828
Recruitment Status : Completed
First Posted : April 12, 2010
Last Update Posted : February 14, 2011
Sponsor:
Information provided by:
University of Washington

Brief Summary:
The purpose of this study is to compare methods for transporting self-collected swabs for HPV testing in 18-24 year old women and to look at risk factors for HPV infection in 18-24 year old women.

Condition or disease
Papillomavirus Infections

Detailed Description:
We propose a cross-sectional study among 150 women in the United States who have used Internet dating sites in the past year in order to examine risk factors for high-risk HPV infections in 18-24 year old online daters, and evaluate strategies for transporting and storing self-collected samples for HPV testing. We will ask participants to complete a written questionnaire on their health, sexual behavior, and attitudes toward self-collecting vaginal swabs, HPV vaccination, and cervical cancer screening. Also, we will ask the women to self-collect two sequential vaginal swab samples that will be transported and stored according to the two strategies described above. Each sample will be tested for type-specific HPV DNA using a PCR-based assay.

Study Type : Observational
Estimated Enrollment : 150 participants
Time Perspective: Cross-Sectional
Official Title: Self-collected Swabs for HPV Testing in 18-24 Year Old Women
Study Start Date : April 2010
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2011



Primary Outcome Measures :
  1. Presence of type-specific HPV DNA in self-collected vaginal swab samples [ Time Frame: Baseline ]

Biospecimen Retention:   Samples With DNA
Self-collected vaginal samples for HPV testing


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Ages Eligible for Study:   18 Years to 24 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
18 to 24 year old women who date online
Criteria

Inclusion Criteria:

  • Have had sex with men
  • Have used the internet to search for romantic partners in the past year (e.g. posted or responded to an ad on an internet dating website or social networking website)

Exclusion Criteria:

  • Pregnant or breastfeeding

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01101828


Locations
United States, Washington
University of Washington
Seattle, Washington, United States, 98195
Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: Rachel L Winer, PhD, MPH University of Washington

Additional Information:
Responsible Party: Rachel L. Winer/Assistant Professor, University of Washington
ClinicalTrials.gov Identifier: NCT01101828     History of Changes
Other Study ID Numbers: 37822-A
First Posted: April 12, 2010    Key Record Dates
Last Update Posted: February 14, 2011
Last Verified: February 2011

Additional relevant MeSH terms:
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Tumor Virus Infections